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Apply to JobJob ID251168BRPosition TitleHead QA for QC OperationsJob DescriptionStein is a site of strategic importance for the manufacturing and launch of innovative medicine. One of the most important pharmaceutical production plants of Novartis Technical Operations is located in Stein: The plant Stein Steriles. The site is launch site & center of excellence worldwide for innovative sterile drug products for injection containing Biologics as well as manufacturing site for clinical supplies of sterile dosage forms required in global clinical studies.



The Head QA for QC owns the quality aspects of all “QC release and monitoring” and Analytical Sciences and Technology relevant processes, ensures training of all QC release delegates and manages the “QA for QC” Operations Steriles Team



The main accountabilities are the following:



• Ensure that all QC and AS&T related processes are defined according to applicable regulations and Novartis quality manuals

• Set up, maintain and execute trainings / education / qualification for all delegates in the review and release process for Stein Steriles QC analysis

• Accountable with the team for analytical change evaluation

• Ensure that deviations, OOS and OOE are investigated and investigation reports are available as well as definition of CAPAs

• Plan, execute and ensure documentation of local quality assessments related to QC activities and ensure global escalation of quality relevant topics according applicable procedures

• Ensure availability of KPIs for all processes related to the position

• Ensure a Lab QA oversight and participates in self inspections

• Support inspections by Health Authorities and customers

• Initiate and implement quality improvement projects

• Responsible for the leadership aspects of the group by ensuring the preparation of job descriptions, performance management plans and conducting employee performance reviews (including hiring, coaching/development, providing an environment that fosters teamwork and assigning responsibility and accountability at proper levels)

Minimum requirements• (Technical) University/academical degree in general or medical microbiology, biochemistry, pharmacy, chemistry or equivalent

• Fluent in German and English (spoken/written)

• Minimum 7 years of experience in a GMP environment (Quality Assurance and Quality Control) in a manufacturing environment within the pharmaceutical industry

• Broad experience in Health Authority interaction

• Previous experience and strong mindset in continuous improvement and change management

• Experience in international, complex and dynamic environmentsDivisionNovartis Technical OperationsBusiness UnitNTO QUALITYLocationSwitzerlandSiteStein (Säckingen)Company/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular

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